Let­ter from FDA out­lin­ing de­fi­cien­cies for lead drug caus­es Ax­some stock to crater. Is a CRL on the way?

The FDA has con­cerns with Ax­some’s lead and po­ten­tial block­buster drug to treat ma­jor de­pres­sive dis­or­der, which sent the com­pa­ny’s stock price down by more than 40% ear­ly Mon­day.

While the com­pa­ny has not yet re­ceived an of­fi­cial CRL from the FDA, Ax­some CEO Her­riot Tabuteau said that the FDA “re­cent­ly no­ti­fied us that they have iden­ti­fied de­fi­cien­cies that pre­clude la­bel­ing dis­cus­sions at this time. We are at­tempt­ing to learn the na­ture of these de­fi­cien­cies with the goal of ad­dress­ing them, how­ev­er, this de­vel­op­ment may lead to a de­lay in the po­ten­tial ap­proval of AXS-05.”

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